Totally Neoadjuvant FOLFOXIRI + Short-course Radiation + XELOX in Patients With Locally Advanced Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT03484221|
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rectal Neoplasms Drug Therapy Radiation||Drug: FOLFOXIRI Radiation: Short-Course Radiation Therapy(5Gy*5) Drug: XELOX||Phase 2|
Neoadjuvant chemoradiation therapy with double cytotoxic agents is the standard treatment for the patients with locally advanced rectal cancer. Conventional treatment reduced the local recurrence but did not prolong the long-term survival. Furthermore, the patients with pathological complete response (pCR) did not benefit from double cytotoxic chemotherapy. Therefore, we chose triple cytotoxic agents FOLFOXIRI as the neoadjuvant chemotherapy. We will evaluate the efficacy and safety of totally neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) followed by short-course radiation and XELOX chemotherapy in the patients with locally advanced rectal cancer to achieve more pCR and longer survival.
In this prospective study, 30 patients with locally advanced rectal cancer will be recruited. Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by TME surgery. PET-CT examination will be performed before and after the 4 cycles of neoadjuvant FOLFOXIRI chemotherapy to assess the SUVmax changes. In addition, the dynamic changes of ctDNA in peripheral blood will be monitored at the PET-CT examination. In the course of treatment, safety evaluation will be carried out according to the standard of adverse reaction classification (CTCAE) 4.0.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Totally Neoadjuvant FOLFOXIRI Chemotherapy Followed by Short-course Radiation and XELOX Chemotherapy in Patients With Locally Advanced Rectal Cancer：an Open-label, Single-arm, Multicenter Phase II Study.|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
Experimental: FOLFOXIRI+short-course radiation+XELOX
Firstly, 4 cycles of neoadjuvant FOLFOXIRI chemotherapy were administered. Subsequently, a short-course radiation therapy (5Gy*5) will be performed. After that, 4 cycles of XELOX chemotherapy will be administered followed by surgery.
IRINOTECAN 150 mg/m^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).
Radiation: Short-Course Radiation Therapy(5Gy*5)
Patients received a short-course radiation therapy(5Gy*5) after 4 cycles of FOLFOXIRI.
OXALIPLATIN 130 mg/m^2 IV over 2-h, day 1 Capecitabine 1000 mg/m^2 twice daily days 1-14 every 3 weeks for 4 cycles.
- The ratio of tumor downstaging to stage 0 and stage I [ Time Frame: 2 years ]Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
- Tumor regression grade (TRG) [ Time Frame: 2 years ]The level of tumor regression under pathological examination
- Disease free survival [ Time Frame: 3 years ]Estimated from the date of surgery to the date of recurrence.
- Overall survival time [ Time Frame: 3 years ]Estimated from the date of enrollment to death from any cause.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 3 years ]The grade of toxicity will be assessed using the NCI-CTCAE version 4.0.
- ctDNA change [ Time Frame: 3 years ]The relationship between ctDNA and survival will be evaluated.
- SUVmax changes [ Time Frame: At the beginning of Cycle 1 and the end of Cycle 4 (each cycle is 14 days) ]Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
- Quality of life (QLQ C30) [ Time Frame: Every 2 weeks after the first treatment until 3 years ]Scores according to EORTC QLQ-C30 scoring manual
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484221
|Contact: Yuanhe Wang, PhDfirstname.lastname@example.org|
|China Medical University||Recruiting|
|Contact: Yuanhe Wang|
|Principal Investigator:||Jingdong Zhang||China Medical University, China|